Federal Register of Legislation - Australian Government

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Administered by: Health
Published Date 18 Oct 2016


Technical Review of the Gene Technology Regulations 2001 – call for submissions


The Gene Technology Regulator has initiated a technical review of the Gene Technology Regulations 2001 (the Regulations) to provide clarity about whether organisms developed using a range of new technologies are subject to regulation as genetically modified organisms (GMOs) and ensure that new technologies are regulated in a manner commensurate with the risks they pose.


The technical review must maintain the current policy settings of the gene technology regulatory scheme, and so cannot alter the definition of ‘GMO’ in the Gene Technology Act 2000. However, it is within the scope of the technical review to exclude specific techniques or organisms from regulation, via listing in the Regulations, if they were not given a clear treatment at the inception of the scheme. It is also within scope to alter exclusions if scientific understanding of the risks particular techniques or organisms pose has since changed.


OGTR has prepared a Discussion Paper canvasing four options for how new technologies could be regulated, which includes consultation questions. OGTR is seeking submissions addressing these consultation questions. Proposals for amendments to other technical or scientific aspects of the GT Regulations are also invited. All proposals must be supported by a rationale and, where possible, a science-based argument.


The Discussion Paper can be accessed via the OGTR website at: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/regs-process-1 


Submissions can be made by email to ogtr@health.gov.au or by mail to:

the Regulations Review

Office of the Gene Technology Regulator (MDP 54)

GPO Box 9848, Canberra ACT 2601.


Submissions will be published on the OGTR website after the consultation period closes, however, information which is of a confidential nature can be treated as such by the OGTR. Please ensure that material supplied in confidence is clearly marked 'IN CONFIDENCE' and is in a separate attachment to non-confidential material.


For privacy reasons, all personal details (e.g. home and email address, signatures, phone, mobile and fax numbers) will be removed from your submission before they are published on the website. Please do not include these details in your submission unless necessary.


Submissions should be received by 2 December 2016